Formulation Development and Evaluation of Fast Dissolving Oral Films of Alprazolam

Main Article Content

Riffat Latif
Muhammad Ashfaq

Abstract

Fast dissolving oral films provide convenient, safe and simple way of drug administration. Moreover they offer improved patient compliance due to straightforward and non-invasive nature. The aim of current research was to develop fast dissolving oral films of alprazolam for treatment of anxiety disorders. Films were developed by solvent casting method using HPMC (Hydroxypropyl Methyl Cellulose) as film former and PEG (Polyethylene Glycol) as plasticizer. All formulation (F1- F12) were assessed for various parameters including thickness, tackiness, percent elongation, folding endurance, tensile strength, contact angle, transparency, content uniformity, disintegration and dissolution times. The thickness of optimized formulation was found to be 65µm and the Tensile strength, Percent elongation, Folding Endurance, Transparency, contact angle, Assay content uniformity, Disintegration Time and Dissolution for optimized formulation were found to be 5.38%, 45%, 290 times, 100.1%, 180o, 98.65%, 20 seconds and 106.6% respectively. Drug release studies displayed 106.60% release of total drug content after time duration of 1.813 minutes. The results of the study concluded that newly developed fast dissolving film of alprazolam have potential to provide fast delivery of the drug and thereby enhanced patient compliance.

Keywords:
Fast dissolving oral films, alprazolam, film formers.

Article Details

How to Cite
Latif, R., & Ashfaq, M. (2019). Formulation Development and Evaluation of Fast Dissolving Oral Films of Alprazolam. Journal of Advances in Medical and Pharmaceutical Sciences, 21(4), 1-20. https://doi.org/10.9734/jamps/2019/v21i430142
Section
Original Research Article

References

Dixit R, Puthli S. Oral strip technology: overview and future potential. Journal of Controlled Release. 2009;139(2):94-107.

Saini S, Nanda A, Dhari J. Formulation, development & evaluation of oral fast dissolving anti-allergic film of levocetrizine dihydrochloride. Journal of Pharmac-eutical Sciences and Research. 2011; 3(7):1322.

Bhyan B, Jangra S, Kaur M, Singh H. Orally fast dissolving films: innovations in formulation and technology. Int J Pharm Sci Rev Res. 2011;9(2):9-15.

Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: An innovative drug delivery system and dosage form. International Journal of Chem Tech Research. 2010;2(1):576-583.

Nimbal GM, Halse S, Naziya FG. Modelling and simulation of thermal actuator using polysilicon material. Journal of Pure Applied and Industrial Physics. 2013;3(3):193-228.

Patel AR, Prajapati DS, Raval JA. Fast dissolving films (FDFs) as a newer venture in fast dissolving dosage forms. International Journal of Drug Development and Research. 2010;2(2):232-246.

Damle B, Tarabar S, Kuruganti U, Crownover P, LaBadie R. Bioequivalence of alprazolam sublingual tablet formulation and alprazolam immediate release tablet in healthy volunteers. J Bioequiv. 2013;5(4): 149-153.

Shirsand S, Suresh S, Swamy P, Kumar DN, Rampure M. Design and evaluation of fast dissolving tablets of clonazepam. Indian Journal of Pharmaceutical Sciences.2008;70(6):791.

Pandya K. Fast dissolving films: A novel approach to oral drug dilivery. Int. Jour. of Pharmamedix India. 2013;1(2).

Mandeep K, Rana A, Nimrata S. Fast dissolving films: An Innovative drug delivery system. International Journal of Pharmaceutical Research & Allied Sciences. 2013;2(1).

Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: A new approach to oral drug delivery system. International Journal of Pharmaceutical Investigation. 2013;3(2):67.

Rathore R, Gupta AK, Parashar AK. Formulation and evaluation of fast dissolving films of granisetron hydrochloride. Journal of Drug Delivery and Therapeutics. 2019;9(2-A):36-38.

Gandhi RB, Robinson JR. Oral cavity as a site for bioadhesive drug delivery. Advanced Drug Delivery Reviews. 1994; 13(1-2):43-74.

Rowland M. Influence of route of administration on drug availability. Journal of Pharmaceutical Sciences. 1972;61(1): 70-74.

Gwee K, Leong Y, Graham C, McKendrick M, Collins S, Walters S, Read N. The role of psychological and biological factors in postinfective gut dysfunction. Gut. 1999; 44(3):400-406.

Mahaguna V, Talbert RL, Peters JI, Adams S, Reynolds TD, Lam FY, Williams IIIRO. Influence of hydroxypropyl methylcellulose polymer on in vitro and in vivo performance of controlled release tablets containing alprazolam. European Journal of Pharmaceutics and Biopharmaceutics. 2003;56(3):461-468.

Evans RL. Alprazolam-XR: A pharmacokinetic review. Psychiatric Annals. 1993;23(10):8-9.

Márquez M, Arenoso H, Caruso N. Efficacy of alprazolam sublingual tablets in the treatment of the acute phase of panic disorders. Actas Esp Psiquiatr. 2011;39(2): 88-94.

Yalkowsky SH, Valvani SC, Johnson BW. In vitro method for detecting precipitation of parenteral formulations after injection. Journal of Pharmaceutical Sciences. 1983;72(9):1014-1017.

Rabinowitz JD, Zaffaroni AC. Delivery of alprazolam, estazolam, midazolam or triazolam through an inhalation route: Google Patents; 2004.

O'Sullivan G, Noshirvani H, Basoglu M, Marks I, Swinson R, Kuch K, Kirby M. Safety and side-effects of alprazolam controlled study in agoraphobia with panic disorder. The British Journal of Psychiatry. 1994;165(1):79-86.

Beyatricks J. Development of fast dissolving oral films containing vitamin b6 for Nausea and Vomiting of Pregnancy (NVP). Journal of Drug Delivery and Therapeutics. 2019;9(3):51-59.

Akca G, Özdemir A, Öner ZG, Şenel S. Comparison of different types and sources of chitosan for the treatment of infections in the oral cavity. Research on Chemical Intermediates. 2018;44(8):4811-4825.

Siemann U. Solvent cast technology–a versatile tool for thin filmproduction Scattering methods and the properties of polymer materials, Springer. 2005;1- 14.

Collins L, Dawes C. The surface area of the adult human mouth and thickness of the salivary film covering the teeth and oral mucosa. Journal of Dental Research. 1987;66(8):1300-1302.

Maddela S, Nalluri BN. Development of Zolmitriptan Mouth Dissolving films: Formulation variables, mechanical properties, and In vitro drug release studies. Development. 2019;12(4).

Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. Fast dissolving films made of maltodextrins. European Journal of Pharmaceutics and Biopharmaceutics. 2008;70(3):895-900.

Saab M, Mehanna MM. Disintegration time of orally dissolving films: various methodologies and in-vitro/in-vivo correlation.Die Pharmazie-An International Journal of Pharmaceutical Sciences. 2019; 74(4);227-230.

Garsuch V, Breitkreutz J.Comparative investigations on different polymers for the preparation of fast‐dissolving oral films. Journal of Pharmacy and Pharmacology.2010;62(4):539-545.